Weight Loss and Appetite Reduction After Percutaneous Electrical Stimulation Dermatome T6

Hospital General Universitario Elche

Status and phase: Completed; Phase 3

Conditions: Weight Loss

Treatments: Procedure: PENS T6; Dietary Supplement: Normocaloric 2000 Kcal/day diet; Dietary Supplement: Hypocaloric 1200 Kcal/day diet; Procedure: TENS T11/T12

Study type: Interventional

Funder types: Other

Identifiers

NCT02810925

ClinGarci 16-2

Details and patient eligibility

About

The patients are randomized into 4 groups : Patients undergoing PENS of dermatome T6 in and a 1200 Kcal diet (Group 1), Patients undergoing PENS T6 and a 2000 Kcal/day, Patients undergoing transcutaneous electrical neurostimulation (TENS) of Dermatomes T11-T12 and following a 1200 Kcal diet and those patients following only a 1200 Kcal diet (Group 4). Weight loss, appetite and ghrelin levels at baseline and after treatment are investigated.

Full description

The patients were randomized into 4 groups using an Internet randomization module: Patients undergoing PENS of dermatome T6 in conjunction with the implementation of a 1200 Kcal diet (Group 1), Patients undergoing PENS T6 and following a normocaloric diet (2000 Kcal/day) (Group 2), Patients undergoing transcutaneous electrical neurostimulation (TENS) of dermatomes in right iliac fossa (Dermatomes T11-T12) and following a hypocaloric diet (1200 Kcal/day) (Group 3) and those patients following only a 1200 Kcal diet (Group 4).

Weight loss, appetite and ghrelin levels, at baseline and after treatment, are investigated.

Enrollment: 200 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with obesity (BMI>30 Kg/m2) or overweight (BMI 25-30 Kg/m2)

Exclusion criteria

• Untreated endocrine disease causing obesity
• Serious psychiatric illness.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 4 patient groups, including a placebo group

PENS T6 and 1200 Kcal/day diet

Experimental group

Description:

Patients undergo 12 sessions of percutaneous electrical stimulation of dermatome T6 (PENS T6), weekly, during 12 weeks. During this period they follow a hypocaloric 1200 Kcal/day diet.

Treatment:

Dietary Supplement: Hypocaloric 1200 Kcal/day diet

Procedure: PENS T6

PENST6 + Normocaloric 2000 Kcal/day diet

Active Comparator group

Description:

Patients undergo 12 sessions of percutaneous electrical stimulation of dermatome T6 (PENS T6), weekly, during 12 weeks. During this period they follow a normocaloric 2000 Kcal/day diet.

Treatment:

Dietary Supplement: Normocaloric 2000 Kcal/day diet

Procedure: PENS T6

TENS T11/ T12 + 1200 Kcal/day diet

Placebo Comparator group

Description:

Patients undergo 12 sessions of transcutaneous electrical stimulation of dermatomes T11-T12 , weekly, during 12 weeks. During this period they follow a hypocaloric 1200 Kcal/day diet.

Treatment:

Dietary Supplement: Hypocaloric 1200 Kcal/day diet

Procedure: TENS T11/T12

1200 Kcal/day diet

Active Comparator group

Description:

Patients follow only a hypocaloric 1200 Kcal/day diet.

Treatment:

Dietary Supplement: Hypocaloric 1200 Kcal/day diet